Press Release

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 3, 2015--
AVEO Oncology (NASDAQ:AVEO) today announced that, following
pre-submission advisory meetings to discuss the potential submission of
a Marketing Authorization Application (MAA) for tivozanib in Europe for
the treatment of renal cell carcinoma (RCC), it has received written
confirmation of support from the Rapporteur and co-Rapporteur for the
filing of such an application. The Rapporteur (from Portugal) and
Co-Rapporteur (from the United Kingdom) are the two appointed members of
the Committee for Medicinal Products for Human Use (CHMP) who would lead
the evaluation of the MAA, if submitted.

The application would be based on the Company’s existing dataset, which
includes results from the Phase 3 TIVO-1 study of tivozanib in the
first-line treatment of RCC in which tivozanib demonstrated a
significant improvement over sorafenib in the study’s primary endpoint
of progression free survival. At the advisory meetings, AVEO provided
data demonstrating that the discordance in overall survival (OS), the
secondary endpoint of the study, was very likely attributable to the
crossover design of the study. The final meeting minutes reflect that
the Rapporteurs “did not see a ‘blocking issue’ with the OS trend” and
that AVEO “clearly presented a credible story for the Rapporteurs to
assess but one which would need to be supported with very careful
reasoning.” AVEO was also reminded that the Rapporteurs “cannot advise
on [the] final outcome of the review.”

“We are pleased that both the Rapporteur and Co-Rapporteur were
supportive of an MAA filing for tivozanib in RCC using TIVO-1 as the
pivotal study,” said Michael Bailey, president and chief executive
officer of AVEO. “We believe tivozanib may provide an important addition
to the clinical armamentarium in the treatment of this disease. Based on
our assessment of the economic and infrastructure requirements
associated with filing an MAA and subsequently launching tivozanib in
Europe, we are evaluating partnership opportunities to take tivozanib
forward in this important market as we continue to prepare for a filing.”

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company committed to
developing targeted therapies through biomarker-driven insights to
provide improvements in patient outcomes where significant unmet medical
needs exist. AVEO’s proprietary Human Response Platform™ has delivered
unique insights into cancer and related disease biology that AVEO is
seeking to leverage in the clinical development strategy of its
therapeutic candidates. For more information, please visit the company’s
website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within
the meaning of The Private Securities Litigation Reform Act of 1995 that
involve substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release are
forward-looking statements. The words “anticipate,” “expect,” “intend,”
“may,” “plan,” “could,” “should,” “seek,” or the negative of these terms
or other similar expressions, are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among
others, statements about: the support of the Rapporteurs for of an MAA
filing for tivozanib in RCC; the imbalance that caused the discordance
in the Phase 3 TIVO-1 trial; and AVEO’s plans and opportunities to take
tivozanib forward. Actual results or events could differ materially from
the plans, intentions and expectations disclosed in the forward-looking
statements that AVEO makes due to a number of important factors,
including risks relating to: AVEO’s ability to demonstrate to the
satisfaction of the FDA, EMA or other equivalent foreign regulatory
agencies, include the Rapporteurs in Europe, the safety, efficacy and
clinically meaningful benefit of its product candidates; AVEO’s ability
to successfully implement its restructuring and strategic plans; AVEO’s
ability to successfully enroll and complete clinical trials of its
product candidates; AVEO’s ability to achieve and maintain compliance
with all regulatory requirements applicable to its product candidates;
AVEO’s ability to obtain and maintain adequate protection for
intellectual property rights relating to its product candidates and
technologies; developments and expenses related to AVEO’s ongoing
shareholder litigation and SEC inquiry; AVEO’s ability to raise the
substantial additional funds required to achieve its goals; unplanned
capital requirements; adverse general economic and industry conditions;
competitive factors; and those risks discussed in the section titled
“Risk Factors” included in AVEO’s most recent Annual Report on Form
10-K, its quarterly reports on Form 10-Q and in its other filings with
the SEC. The forward-looking statements in this press release represent
AVEO’s views as of the date of this press release. AVEO anticipates that
subsequent events and developments will cause its views to change.
However, while AVEO may elect to update these forward-looking statements
at some point in the future, it specifically disclaims any obligation to
do so. You should, therefore, not rely on these forward-looking
statements as representing AVEO’s views as of any date subsequent to the
date of this press release.